Cleared Traditional

K913746 - SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM

K913746 is an FDA 510(k) clearance for SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM, manufactured by Peripheral Systems Group. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K913746 · Peripheral Systems Group · Radiology device
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Dec 1991
Decision
118d
Days
Class 2
Risk

K913746 is an FDA 510(k) clearance for the SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Peripheral Systems Group (Mountain View, US). The FDA issued a Cleared decision on December 17, 1991 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Peripheral Systems Group devices

FDA 510(k) Submission Details - K913746

510(k) Number K913746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1991
Decision Date December 17, 1991
Days to Decision 118 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 348
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K913746.
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BIOPSY ACCESSORIES FOR ULTRASOUND PROBES
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ACUSON V510 TRANSDUCER
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CVIS INSIGHT IMAGING CATHETERS
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